Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers


1. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide
2. Daliresp
1. 162401-32-3
2. Daxas
3. 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
4. Daliresp
5. By217
6. Byk20869
7. By-217
8. B9302-107
9. By 217
10. 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide
11. Roflumilast (daxas)
12. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-
13. Byk-20869
14. 0p6c6zop5u
15. Chembl193240
16. Chebi:47657
17. 3-cyclopropylmethoxy-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
18. Byk 20869
19. Mfcd00938270
20. B 9302-107
21. Rof
22. Libertek
23. Roflumilast [usan]
24. B-9302-107
25. Roflumilast [usan:inn]
26. Unii-0p6c6zop5u
27. Roflumilastum
28. Roflumilast (jan/usan/inn)
29. Apta-2217
30. 1xmu
31. 1xoq
32. Daliresp (tn)
33. Roflumilast- Bio-x
34. 3g4l
35. Roflumilast [mi]
36. Roflumilast [inn]
37. Roflumilast [jan]
38. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide
39. Roflumilast [vandf]
40. Roflumilast [mart.]
41. Schembl19158
42. Roflumilast [who-dd]
43. Mls006010074
44. Roflumilast [ema Epar]
45. Gtpl6962
46. Dtxsid8044123
47. Apta 2217
48. Bdbm14774
49. Roflumilast, >=98% (hplc)
50. Amy4219
51. Ex-a059
52. Roflumilast [orange Book]
53. Hms3655p21
54. Hms3748c19
55. Hms3884f09
56. Zinc592419
57. Act02619
58. Bcp03736
59. S2131
60. Arq-151/zoryve (roflumilast Cream)
61. Akos005146309
62. Am84550
63. Ccg-268678
64. Cs-0963
65. Db01656
66. Pb29130
67. Ncgc00346566-01
68. Ncgc00346566-09
69. Ac-23383
70. As-14120
71. Br164364
72. Hy-15455
73. Smr002530074
74. Sy008710
75. Bcp0726000146
76. Ft-0660846
77. R0193
78. Sw220196-1
79. A24672
80. D05744
81. Ab01565852_02
82. 401r323
83. Q693482
84. J-510858
85. Brd-k03194791-001-02-2
86. 3- Cyclo-propylmethoxy-4-difluoromethoxy-n- [3, 5-di-chloropyrid-4-yl]- Benzamid
87. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-
88. N-(3,5-dichloropyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide
| Molecular Weight | 403.2 g/mol |
|---|---|
| Molecular Formula | C17H14Cl2F2N2O3 |
| XLogP3 | 4.6 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 7 |
| Exact Mass | 402.0349540 g/mol |
| Monoisotopic Mass | 402.0349540 g/mol |
| Topological Polar Surface Area | 60.4 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 475 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Daliresp |
| PubMed Health | Roflumilast (By mouth) |
| Drug Classes | Respiratory Agent |
| Drug Label | The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm... |
| Active Ingredient | Roflumilast |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 500mcg |
| Market Status | Prescription |
| Company | Forest Res Inst |
| 2 of 2 | |
|---|---|
| Drug Name | Daliresp |
| PubMed Health | Roflumilast (By mouth) |
| Drug Classes | Respiratory Agent |
| Drug Label | The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm... |
| Active Ingredient | Roflumilast |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 500mcg |
| Market Status | Prescription |
| Company | Forest Res Inst |
Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
FDA Label
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Chronic obstructive pulmonary disease
Roflumilast (and its active metabolite, roflumilast N-oxide) increases cyclic adenosine-3, 5-monophosphate (cAMP) in lung cells by inhibiting PDE4. Increased cAMP activates PKA, which inactivates transcription factors involved in inflammation. Romflumilast also decreases the amount of sputum neutrophils and eosinophils in COPD patients.
R03DX07
R03DX08
R03DX07
R03DX07
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
R - Respiratory system
R03 - Drugs for obstructive airway diseases
R03D - Other systemic drugs for obstructive airway diseases
R03DX - Other systemic drugs for obstructive airway diseases
R03DX07 - Roflumilast
Absorption
After a 500mcg dose, the bioavailability of roflumilast is about 80%. In the fasted state, maximum plasma concentrations are reached in 0.5 to 2 hours. While in the fed state, Cmax is reduced by 40%, Tmax is increased by one hour, and total absorption is unchanged.
Route of Elimination
Roflumilast is excreted 70% in the urine as roflumilast N-oxide.
Volume of Distribution
Roflumilast has a Vd of 2.9L/kg with a dose of 500mcg. Permeability of roflumilast across the blood-brain barrier appears to be poor in rat studies.
Clearance
~9.6 L/hour.
Roflumilast is metabolized to roflumilast N-oxide, the active metabolite of roflumilast in humans, by CYP3A4 and CYP1A2.
Plasma half-life of roflumilast is 17 hours and its metabolite is 30 hours (oral dose).
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-07-23
DMF Number : 28471
Submission : 2014-07-31
Status : Active
Type : II
NDC Package Code : 64552-4053
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2016-12-29
Registration Number : Su259-4-ND
Manufacturer Name : Interquim, SA
Manufacturer Address : Joan Buscalla 10, E-08173 Sant Cugat del Valles, Barcelona, Spain
| Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4067
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4096
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-11
Pay. Date : 2014-08-04
DMF Number : 28440
Submission : 2014-09-04
Status : Active
Type : II
NDC Package Code : 65015-850
Start Marketing Date : 2015-02-20
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-21
Pay. Date : 2021-03-04
DMF Number : 35661
Submission : 2021-03-11
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-08
Pay. Date : 2014-03-13
DMF Number : 26764
Submission : 2012-12-27
Status : Active
Type : II
NDC Package Code : 54245-7016
Start Marketing Date : 2013-12-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39781
Submission : 2024-03-28
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-07-23
DMF Number : 28471
Submission : 2014-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27779
Submission : 2014-03-28
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2018-06-29
Pay. Date : 2018-06-04
DMF Number : 32851
Submission : 2018-06-01
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-01-21
Pay. Date : 2014-09-10
DMF Number : 28506
Submission : 2014-07-22
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-11-17
Pay. Date : 2014-08-14
DMF Number : 28516
Submission : 2014-08-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-07-03
DMF Number : 27612
Submission : 2013-11-30
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-09-08
Pay. Date : 2014-03-13
DMF Number : 26764
Submission : 2012-12-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-04-21
Pay. Date : 2021-03-04
DMF Number : 35661
Submission : 2021-03-11
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-11-11
Pay. Date : 2014-08-04
DMF Number : 28440
Submission : 2014-09-04
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-14
DMF Number : 28657
Submission : 2014-10-31
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...

Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm : Unit-l, Sy. No. 213, 214 & 255, Bonthapally (Village),Gummadidala (Mandal), Sang...

Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2016-12-29
Registration Number : Su259-4-ND
Manufacturer Name : Interquim, SA
Manufacturer Address : Joan Buscalla 10, E-08173 Sant Cugat del Valles, Barcelona, Spain
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-07-20
Registration Number : Su258-14-ND
Manufacturer Name : MSN Laboratories PVT.LTD
Manufacturer Address : Sy. No. 317 , 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal),...

Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2017-04-03
Registration Number : Su258-2-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2024-11-29
Registration Number : 1962-9-ND
Manufacturer Name : Polaris AI Pharma Co., Ltd.
Manufacturer Address : 10-11, Block 34, Balan Industrial Complex, 25 Balan Industrial Complex-ro, Hyangnam-e...

Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-04-29
Registration Number : Su5550-1-ND
Manufacturer Name : Takeda GmbH, Production site...
Manufacturer Address : Robert-Bosch-Strass 8 78224 Singen Germany

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4067
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4053
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4096
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-222
Start Marketing Date : 2023-12-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 73377-310
Start Marketing Date : 2025-02-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 65977-0111
Start Marketing Date : 2011-02-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 14501-0078
Start Marketing Date : 2012-03-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65129-1319
Start Marketing Date : 2013-12-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 61730-0010
Start Marketing Date : 2023-12-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 82245-0118
Start Marketing Date : 2018-01-23
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...

About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

About the Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development...

About the Company : Founded in 2007, Melody Healthcare is a rapidly growing, quality-oriented leading manufacturer of APIs, with a distinct emphasis on the development and production of technology-dri...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Roflumilast-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Senores Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 21, 2025
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Senores Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets
Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.
Product Name : Roflumilast-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
February 21, 2025
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
In the termination of the deal involving Roflumilast, the focus on targeting Phosphodiesterase 4 for plaque psoriasis remains undisclosed.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Zoryve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Kowa Pharmaceuticals America
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination January 26, 2026

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Kowa Pharmaceuticals America
Deal Size : Undisclosed
Deal Type : Termination
Arcutis Biotherapeutics Ends Promotion Agreement with Kowa
Details : In the termination of the deal involving Roflumilast, the focus on targeting Phosphodiesterase 4 for plaque psoriasis remains undisclosed.
Product Name : Zoryve
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 26, 2026

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
ARQ-154 (Roflumilast) is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of psoriasis.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: ARQ-154
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 14, 2026

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ARQ-154 (Roflumilast) is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of psoriasis.
Product Name : ARQ-154
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 14, 2026

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Roflumilast is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
The Safety and Efficacy of Roflumilast Foam in HS
Details : Roflumilast is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 04, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Roflumilast, a phosphodiesterase 4 inhibitor, shows promise in treating atopic dermatitis.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Zoryve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 30, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Arcutis Debuts ZORYVE® Cream 0.05% for Mild to Moderate Atopic Dermatitis in Children 2-5
Details : Roflumilast, a phosphodiesterase 4 inhibitor, shows promise in treating atopic dermatitis.
Product Name : Zoryve
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 30, 2025

Details:
Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Vitiligo.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Arcutis Biotherapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 05, 2025

Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Arcutis Biotherapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Roflumilast Foam 0.3% Safety and Efficacy In Pediatric NSV
Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Vitiligo.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 05, 2025

Details:
Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Arcutis Biotherapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2025

Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Arcutis Biotherapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety & Efficacy of Roflumilast 0.3% Foam in Hidradenitis Suppurativa
Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 22, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Zoryve (roflumilast) is a PDE4 inhibitor steroid-free foam which is indicated for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Zoryve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 22, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Arcutis’ ZORYVE Foam 0.3% FDA Approved for Plaque Psoriasis Age 12+
Details : Zoryve (roflumilast) is a PDE4 inhibitor steroid-free foam which is indicated for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older.
Product Name : Zoryve
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 22, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Zoryve (roflumilast) is a once-daily, PDE4 inhibitor steroid-free cream which is being investigated in 2-5 years of age patients with atopic dermatitis.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Zoryve
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts sNDA for Arcutis’ ZORYVE Cream for Pediatric Atopic Dermatitis
Details : Zoryve (roflumilast) is a once-daily, PDE4 inhibitor steroid-free cream which is being investigated in 2-5 years of age patients with atopic dermatitis.
Product Name : Zoryve
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 26, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.
Lead Product(s): Roflumilast,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study
Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 18, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CAS Number : 5911-08-0
End Use API : Roflumilast
About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...
CAS Number : 7051-34-5
End Use API : Roflumilast
About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...
CAS Number : 2516-33-8
End Use API : Roflumilast
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

methyl 4-(difluoromethoxy)-3-hydroxybenzoate
CAS Number : 1159429-52-3
End Use API : Roflumilast
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

CAS Number : 7051-34-5
End Use API : Roflumilast
About The Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...

CAS Number : 516-12-1
End Use API : Roflumilast
About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

CAS Number : 139-85-5
End Use API : Roflumilast
About The Company : V & V Pharma Industries is a Manufacturer & Exporter of Active Pharmaceutical Ingredients (API's), Pharmaceutical Intermediates & Specialty Chemicals. V & V Pha...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Dosage Form : Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Global Sales Information
Market Place
Reply
17 Sep 2025
Reply
23 Aug 2025
Reply
22 Apr 2025
Reply
13 Dec 2024
Reply
24 Feb 2023
Reply
10 Sep 2022
Reply
24 Mar 2022
Reply
04 Aug 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
78
PharmaCompass offers a list of Roflumilast API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Roflumilast manufacturer or Roflumilast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roflumilast manufacturer or Roflumilast supplier.
PharmaCompass also assists you with knowing the Roflumilast API Price utilized in the formulation of products. Roflumilast API Price is not always fixed or binding as the Roflumilast Price is obtained through a variety of data sources. The Roflumilast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Roflumilast, Daxas manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roflumilast, Daxas, including repackagers and relabelers. The FDA regulates Roflumilast, Daxas manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roflumilast, Daxas API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Roflumilast, Daxas manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roflumilast, Daxas supplier is an individual or a company that provides Roflumilast, Daxas active pharmaceutical ingredient (API) or Roflumilast, Daxas finished formulations upon request. The Roflumilast, Daxas suppliers may include Roflumilast, Daxas API manufacturers, exporters, distributors and traders.
click here to find a list of Roflumilast, Daxas suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roflumilast, Daxas DMF (Drug Master File) is a document detailing the whole manufacturing process of Roflumilast, Daxas active pharmaceutical ingredient (API) in detail. Different forms of Roflumilast, Daxas DMFs exist exist since differing nations have different regulations, such as Roflumilast, Daxas USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roflumilast, Daxas DMF submitted to regulatory agencies in the US is known as a USDMF. Roflumilast, Daxas USDMF includes data on Roflumilast, Daxas's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roflumilast, Daxas USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roflumilast, Daxas suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Roflumilast, Daxas Drug Master File in Korea (Roflumilast, Daxas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Roflumilast, Daxas. The MFDS reviews the Roflumilast, Daxas KDMF as part of the drug registration process and uses the information provided in the Roflumilast, Daxas KDMF to evaluate the safety and efficacy of the drug.
After submitting a Roflumilast, Daxas KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Roflumilast, Daxas API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Roflumilast, Daxas suppliers with KDMF on PharmaCompass.
A Roflumilast, Daxas written confirmation (Roflumilast, Daxas WC) is an official document issued by a regulatory agency to a Roflumilast, Daxas manufacturer, verifying that the manufacturing facility of a Roflumilast, Daxas active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Roflumilast, Daxas APIs or Roflumilast, Daxas finished pharmaceutical products to another nation, regulatory agencies frequently require a Roflumilast, Daxas WC (written confirmation) as part of the regulatory process.
click here to find a list of Roflumilast, Daxas suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Roflumilast, Daxas as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Roflumilast, Daxas API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Roflumilast, Daxas as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Roflumilast, Daxas and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Roflumilast, Daxas NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Roflumilast, Daxas suppliers with NDC on PharmaCompass.
Roflumilast, Daxas Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Roflumilast, Daxas GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Roflumilast, Daxas GMP manufacturer or Roflumilast, Daxas GMP API supplier for your needs.
A Roflumilast, Daxas CoA (Certificate of Analysis) is a formal document that attests to Roflumilast, Daxas's compliance with Roflumilast, Daxas specifications and serves as a tool for batch-level quality control.
Roflumilast, Daxas CoA mostly includes findings from lab analyses of a specific batch. For each Roflumilast, Daxas CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Roflumilast, Daxas may be tested according to a variety of international standards, such as European Pharmacopoeia (Roflumilast, Daxas EP), Roflumilast, Daxas JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Roflumilast, Daxas USP).